EP0225803B1 - Fabrication de comprimés - Google Patents

Fabrication de comprimés Download PDF

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Publication number
EP0225803B1
EP0225803B1 EP86309565A EP86309565A EP0225803B1 EP 0225803 B1 EP0225803 B1 EP 0225803B1 EP 86309565 A EP86309565 A EP 86309565A EP 86309565 A EP86309565 A EP 86309565A EP 0225803 B1 EP0225803 B1 EP 0225803B1
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EP
European Patent Office
Prior art keywords
dies
die
lubricant
punches
tablets
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
EP86309565A
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German (de)
English (en)
Other versions
EP0225803A1 (fr
Inventor
John Nicholas Staniforth
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University of Bath
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University of Bath
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Publication date
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Publication of EP0225803A1 publication Critical patent/EP0225803A1/fr
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Expired legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B30—PRESSES
    • B30B—PRESSES IN GENERAL
    • B30B15/00—Details of, or accessories for, presses; Auxiliary measures in connection with pressing
    • B30B15/0005—Details of, or accessories for, presses; Auxiliary measures in connection with pressing for briquetting presses
    • B30B15/0011—Details of, or accessories for, presses; Auxiliary measures in connection with pressing for briquetting presses lubricating means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B30—PRESSES
    • B30B—PRESSES IN GENERAL
    • B30B11/00—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
    • B30B11/02—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space
    • B30B11/08—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space co-operating with moulds carried by a turntable
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S425/00—Plastic article or earthenware shaping or treating: apparatus
    • Y10S425/115—Lubricator

Definitions

  • This invention is concerned with the production of tablets by the compression of powders and granules. More particularly the invention is concerned with the production of tablets in a rotary press.
  • Pharmaceutical tablets are usually prepared by the instantaneous compression of a powder, comprising the active ingredient and an excipient, between two punches in a die.
  • the force for compression may be supplied by either the upper punch or by both the upper and lower punches, but in neither case does all of the applied force go into compressing the powder. Although some of the force is lost in heat and sound energy a major proportion is absorbed in overcoming die wall friction. These frictional forces are sometimes sufficiently great as to prevent tablet compression altogether, and in other cases the appearance of the tablets is unacceptable; for example the tablets may be chipped, capped or laminated rendering them unsuitable for further process.
  • US 4 047 866 describes a rotary tablet press for preparing pharmaceutical tablets in the manner described above and identifies the need to add lubricants, particularly in high speed tablet machines.
  • the lubricant which may be magnesium stearate, incorporated in the powder or granules to be tabletted is normally in a proportion of from 0.25% to 1% by weight.
  • Magnesium stearate has been found to be one of the most efficient tablet lubricants and it also acts as an antiadherant, preventing powder from sticking to punch faces and die walls.
  • Other lubricant powders may, however be used as, for example, salts of benzoic acid and polyethylene glycols.
  • magnesium stearate lubricant has, however, given rise to a number of problems, especially in the production of pharmaceutical tablets but also for other moulded products.
  • the principal problems are as follows:
  • FR-A 2 253 570 describes an apparatus for lubricating the inside walls of a static mould for use in making a sintered part.
  • the mould has an open top and a pivoted filling shoe can be brought over the open top of the mould.
  • a first pivoting of the filling shoe an electrically charged lubricant is injected into the mould cavity, the filling shoe is then pivoted further to allow the powder to form the sintered part to be loaded into the mould.
  • the filling shoe is pivoted away from a position overhanging the mould and a plunger is then brought down into the mould for compressing the powder in the mould. After compression the compacted part is subjected to a sintering process.
  • a process for the manufacture of tablets by compression of a tablet material in the form of a powder or granules in a rotary press comprises the steps of:
  • the lubricant particles may be positively or negatively charged and, while it is envisaged that an electrostatic charge would be imparted temporarily, an electret charge could be implanted.
  • the moulded product is a pharmaceutical tablet and the lubricant is magnesium stearate, and hereinafter the lubricant will be described with reference to magnesium stearate although it will be appreciated that other substances suitable as die lubricants may be used.
  • the charging of the magnesium stearate particles may be effected by means of a corona discharge system or some other such charging system. Alternatively it would be possible to charge the particles triboelectrically, for example by feeding them rapidly through a nozzle. Preferably the magnesium stearate particles are charged to a potential in the range of 1 to 100 kV.
  • the magnesium stearate is conveniently mixed with a part of the excipient or carrier, for example, microcrystalline cellulose, lactose or starch, before it is electrostatically charged and fed to the die.
  • the mixing time of the magnesium stearate with the excipient is not critical and, in fact, overmixing may be ad- vanageous, whereas as mentioned above the mixing time is critical when the magnesium stearate is mixed in with the whole of the moulding or tablet formulation.
  • magnesium stearate In the process of the invention a much lower quantity of magnesium stearate is used, for example, approximately one-hundreth of that employed in the known conventional moulding process.
  • the magnesium stearate may be approximately 0.25 to 1.0% by weight of the mixture with the excipient used in the present process, preferably 0.5% by weight.
  • a small quantity of surfactant for example, from 2 to 5% by weight of magnesium lauryl sulphate, may be incorporated in the mixture of magnesium stearate and excipient. This has the particular advantage in the case of water soluble or effervescent pharmaceutical tablets that completely clear solutions free from scum are obtained.
  • a glidant may also be added to the magnesium stearate-excipient mixture but will more usually be incorporated in the main moulding powder containing, in the case of pharmaceutical tablets, the active ingredient.
  • the magnesium stearate and excipient powder mixture may be filled into a hopper of a dry powder electrostatic charging unit.
  • a spray nozzle from the charging unit may be positioned so as to direct a fine spray of electrostatically charged particles into the front section of a specially constructed feed device for the dies of a rotary press.
  • the charged particles are attracted to the earthed metal surfaces closest to it which include the upper and lower tablet punch faces and the exposed die wall.
  • the feed rate of the lubricant powder (magnesium stearate and excipient) and charging current and voltage may be adjusted to gived optimum lubrication of a given formulation.
  • the process of the present invention enables tablets, especially pharmaceutical tablets, to be produced which are substantially stronger, for example, twice as strong, than those produced by the known conventional methods, yet have comparable dissolution rates.
  • tablets produced by the process of the invention have faster dissolution rates than conventionally produced tablets.
  • the present invention also provides a rotary press for the manufacture of tablets by compression of tablet material in the form of a powder or granules, the rotary press including:
  • the electrical potential of the dies and the punches is maintained at earth potential.
  • the lubricant particles are electrically charged and, while, as already indicated, it is possible to implant a permanent electret charge into them, it is preferred to impart a temporary electrostatic charge.
  • the feed for supplying electrically charged particles preferably includes means for imparting an electrostatic charge to the lubricant particles; the charge imparting means may comprise a corona charging system.
  • the feed for supplying electrically charged particles may include a feed frame made of electrically insulating material, positioned in advance of the filling station and arranged to receive the charged lubricant particles prior to their attraction onto the punches and into the dies.
  • the rotary press shown in the drawing is in most respects entirely conventional.
  • the press has a circular die table 1 mounted for rotation about its central axis.
  • a plurality of dies 2 are located in the table 1.
  • Above and aligned with each die 2 is an associated upper punch 3 mounted for sliding movement into and away from the die in an upper punch holder 4 which, in turn, is arranged for rotation with the die table 1.
  • Below and aligned with each die 2 is an associated lower punch 5 mounted for sliding movement into and away from the die in a lower punch holder 6 which, in turn, is arranged for rotation with the die table 1.
  • Each of the upper punches 3 has a cam follower 7 at its upper end and similarly each of the lower punches 5 has a cam follower 8 at its lower end.
  • the cam followers 7 rest on a stationary fixed upper cam track 9 while the cam followers 8 rest on a stationary fixed lower cam track 10.
  • the die table 1, dies 2, punches 3, 5 and punch holders 4, 6 are made of metal.
  • the lower cam track 10 is interrupted at one position by a ramp 11 the height of which can be screw- adjusted and at another position by the head of an ejection knob 12 which is also screw-adjustable.
  • a pair of compression rolls 13 are also associated with the upper and lower cam tracks 10 and 11.
  • the press has a main hopper 14 for feeding the powder or granules to be tabletted.
  • this powder would include lubricant particles but in the described apparatus that is not necessary.
  • the hopper 14 has an outlet leading to a stationary feed frame or a force feeder with moving paddles 15 immediately about the die table 1.
  • the base of the frame 15 lies immediately adjacent to the . top of the die table 1 and has apertures which allow powder or granules to pass from the compartment into the dies 2.
  • a stationary blade 16 is provided for scraping excess powder or granules away from the dies 2.
  • the apparatus is distinguished from a conventional rotary press by the provision of a supplementary feed frame 17 made partly of insulating material adjacent the frame 15.
  • the supplementary feed frame is supplied with a spray of electrostatically charged lubricant powder from a feed and corona charging device 18 which will now be described.
  • the device 18 has a powder hopper 19 in which a mixer 20 is provided.
  • the hopper 19 has an outlet 21 to which one end of a conduit 22 is connected; an inlet 23 for compressed air is provided in the conduit 22 adjacent the outlet 21.
  • the other end of the conduit 22 is connected to the corona charging and spraying head 25.
  • the spraying head 25 has an outlet nozzle 24 in the centre of which an electrically conducting spike 26 is provided.
  • the spike 26 is electrically connected to a source of high voltage 31 (not shown in Fig. 1 but shown in Fig. 4) via one or more conduits 27 containing an electrically conducting gel.
  • corona charging device described is not in itself a novel device and such a device is sold in the United Kingdom by Volstatic Coatings Ltd..
  • Lubricant powder in the hopper 19 falls to the outlet 21 of the hopper and is blown from there along the conduit 22 by compressed air entering through the inlet 23.
  • the powder is thus carried to the head 25 and is sprayed out of the nozzle 24 around the spike 26.
  • the spike 26 is maintained at a potential in the range of 1 to 100 kV, preferably 60 kV and as a result the air in the region of the nozzle 24 becomes charged and a charge (which may be positive or negative) is therefore transferred to the powder as it is sprayed.
  • the die table 1, dies 2, punches 3, 5 and punch holders 4, 6 are all made from electrically conducting material and the whole assembly is maintained at earth potential. Thus, powder sprayed out of the nozzle 24 is attracted to adjacent earthed surfaces and these include the working faces of passing upper and lower punches 3, 5 and exposed parts of passing dies 2.
  • a given die 2 After receiving a coating of lubricant powder a given die 2, having an associated lower punch 5 engaged in the die and upper punch 3 positioned above and clear of the die, moves on to a position underneath the feed frame 15 where the die is filled with powder.
  • the cam follower 8 As the die moves to that position the cam follower 8 is caused to move down by the downwardly sloping cam track 10 so that the lower punch 5 only just projects into the die and the die is therefore almost entirely filled with powder.
  • the cam follower 8 subsequently reaches the ramp 11 and is driven upwardly thereby expelling powder from the die. While the cam follower 8 is on the top of the ramp 11 the blade 16 scrapes away excess powder from above the die.
  • the lower punch 5 is lowered as the cam follower 8 returns to the cam track 10 and the upper punch 3 drops as the cam follower 7 slides down the inclined upper cam track 9.
  • the upper and lower punches 3, 5 are finally forced together by the compression rollers 13 compressing the powder in the die 2 and forming a tablet.
  • the upper punch 3 is raised to a position above and clear of the die and the lower punch 5 also raised until the tablet is flush with the die table 2 at which stage the tablet is swept away into a collector (not shown) by a wall immediately upstream of the supplementary feed frame 17. The cycle of operation is then repeated.
  • the position of the nozzle 24 relative to the dies and punches is not critical but a good position can be determined readily by experiment and similarly the best charging conditions can be determined by experiment. Charging has been accomplished successfully with the spike 26 maintained at a potential of 60 kV, the current passing through the spike in this case being 50 ⁇ A. It is believed however that other charging conditions in the range of 1 to 100 kV and 1 to 100 ⁇ A could be satisfactory.
  • a tablet moulding powder was prepared by mixing 99 parts of Tablettose with
  • Tablettose is the trade name of a direct compression lactose.
  • Tablets were prepared in accordance with the process of the invention by first imparting an electric charge to the lubricant formulation as described above and feeding the charged lubricant formulation to the die of a rotary press in advance of the tablet moulding powder.
  • a tablet moulding powder was prepared by mixing 99 parts of Tablettose with
  • tensile strengths a measure of the tablet resistance to mechanical crushing, for the tablets obtained in Examples 1 and 2 is shown in Fig. 1A in comparison with the strengths of tablets produced by conventional methods using the same die wall percentages of magnesium stearate as in Examples 1 and 2.
  • Fig. 1 A is in the form of a bar graph with the bars being referenced 1, 2, 3 and 4. Bars 3 and 4 show the results with tablets produced in accordance with Examples 1 and 2 respectively while bars 1 and 2 show the strengths of tablets produced by conventional methods using the same die wall percentages of magnesium stearate as in Examples 1 and 2.
  • the symbol "I” at the top of each bar graph shows 95 per cent confidence limits about the mean.
  • the "y" axis of the bar graph shows the crushing force in Newtons that the tablet withstood.
  • Example 1 was also conducted with a lubrication formulation of 5 parts of magnesium stearate to 95 parts of Tablettose and with this formulation the tablet withstood a crushing force of just under 40 N.
  • a tablet moulding powder was made up from 100 parts of Fast flo:
  • Fast flo is the trade name of a direct compression lactose.
  • a moulding powder was made up from 100 parts of Fast flo:
  • a tablet moulding powder was made up from
  • a tablet moulding powder was made up from
  • the 5.0 per cent magnesium lauryl sulphate being included as a solid surface active agent which is sufficient to solubilise the magnesium stearate when the tablet dissolves.
  • the formulation is therefore suitable for producing tablets which will dissolve in water to give a clear solution.
  • an effervescent couple for example, citric acid and sodium bicarbonate
  • a tablet moulding powder was prepared by mixing
  • Avicel is the trade name of a direct compression a-cellulose and Microtal is the trade name of a direct compression sucrose.
  • a tablet moulding powder was made up from
  • the tablets obtained in the above Examples contained only trace quantities of magnesium stearate equivalent to probably less than 5 microgrammes of magnesium stearate in a 500 milligramme tablet. This compares with 5000 microgrammes of magnesium stearate contained in a 500 milligramme tablet at a 1 per cent level produced by a conventional compression moulding method.
  • Figs. 2 and 3 illustrate this point. Each figure shows a print out obtained from spectral analysis of the surface of a tablet.
  • Fig. 3 shows the results for four tablets A1 to A4 produced by a conventional lubrication technique and it will be seen that in each case there is a clear peak in the print out indicating the presence of the magnesium stearate.
  • Fig. 2 shows the results for four tablets B1 to B4 produced by the process of the invention and in each case there is no clear peak at all in the print out, the amount of magnesium stearate being sufficiently low that the "peak" is lost in the general background noise.
  • FIG. 4 An example of the arrangement of the charging apparatus around the tablet is shown in Fig. 4 of the accompanying drawings in which parts corresponding to those shown in Fig. 1 are referenced by the same reference numerals.
  • the arrangement shown is one that has been used in laboratory tests.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Application Of Or Painting With Fluid Materials (AREA)
  • Moulds For Moulding Plastics Or The Like (AREA)

Claims (13)

1. Procédé pour la fabrication de comprimés par compression d'une matière pour comprimés sous la forme d'une poudre ou de granules dans une presse rotative, procédé qui comprend les étapes consistant à:
faire tourner une pluralité de matrices (2) autour d'un axe central de la presse, chaque matrice (2) étant combinée à des poinçons (3, 5) qui tournent avec la matrice;
remplir les matrices (2) avec de la matière pour comprimés, devant être comprimée, pendant que les matrices tournent autour de l'axe central et qu'elles passent à travers un poste de remplissage;
comprimer la matière pour comprimés dans les matrices (2) entre des faces travaillantes des poinçons (3, 5) pour former des comprimés; et
éjecter les comprimés des matrices (2);
caractérisé en ce que le procédé comprend en outre les étapes consistant à:
charger électriquement un lubrifiant en maintenant les matrices (2) et les poinçons (3, 5) à un potentiel électrique qui diffère de celui du lubrifiant; et
amener le lubrifiant à une région de la presse située avant le poste de remplissage et à partir de laquelle des particules de lubrifiant sont attirées, sous l'effet de leur charge électrique, sur les poinçons (3, 5) et dans les matrices (2) pendant que celles-ci tournent et qu'elles traversent ladite région vers le poste de remplissage.
2. Procédé selon la revendication 1, dans lequel chaque matrice (2) est combinée à un poinçon supérieur (3) et un poinçon inférieur (5), le poinçon supérieur (3) étant placé à distance au-dessus de la matrice (2) pendant le remplissage de la matrice avec de la matière pour comprimés.
3. Procédé selon la revendication 1 ou 2, dans lequel le lubrifiant est du stéarate de magnésium.
4. Procédé selon l'une quelconque des revendications 1 à 3, dans lequel le comprimé est un comprimé pharmaceutique.
5. Procédé selon l'une quelconque des revendications 1 à 4, dans lequel la charge des particules de lubrifiant est produite au moyen d'un système à décharge lumineuse.
6. Procédé selon l'une quelconque des revendications 1 à 4, dans lequel les particules de lubrifiant sont chargées par voie triboélectrique.
7. Procédé selon l'une quelconque des revendications 1 à 6, dans lequel les particules de lubrifiant sont chargées à un potentiel de 1 à 100 kV.
8. Procédé selon l'une quelconque des revendications 1 à 7, dans lequel le lubrifiant est mélangé avec une partie de l'excipient utilisé dans la composition de moulage.
9. Presse rotative pour la fabrication de comprimés par compression d'une matière pour comprimés sous la forme d'une poudre ou de granules, presse qui comporte:
une pluralité de matrices (2) disposées rotatives autour d'un axe central de la presse,
une pluralité de poinçons (3, 5), chaque matrice (2) étant combinée à des poinçons (3, 5) qui tournent avec la matrice,
un poste de remplissage auquel sont prévus des moyens (14, 15) pour remplir les matrices (2) avec de la matière pour comprimés, devant être comprimée, pendant qu'elles tournent autour de l'axe central et qu'elles passent à travers le poste de remplissage,
caractérisée en ce que l'appareil comporte en plus
une alimentation (18) pour amener des particules chargées électriquement à une région de la presse située avant le poste de remplissage, les matrices (2) et les poinçons (3, 5) étant agencés pour traverser cette région, l'agencement étant tel que les particules de lubrifiant sont attirées, sous l'effet de leur charge électrique, sur les poinçons (3, 5) et dans les matrices (2) pendant que celles-ci tournent et qu'elles traversent ladite région avant de passer à travers le poste de remplissage, et
un moyen pour maintenir les matrices (2) et les poinçons (3, 5) à un potentiel électrique qui diffère de celui des particules de lubrifiant.
10. Presse rotative selon la revendication 9, dans laquelle chague matrice (2) est combinée à un poinçon supérieur et un poinçon inférieur, le poinçon supérieur étant agencé pour être placé à distance au-dessus de la matrice pendant le remplissage de la matrice avec de la matière pour comprimés.
11. Presse rotative selon la revendication 9 ou 10, dans laquelle l'alimentation (18) pour amener des particules chargées électriquement, comporte un système à décharge lumineuse pour charger les particules de lubrifiant.
12. Presse rotative selon la revendication 9 ou 10, dans laquelle l'alimentation (18) pour amener des particules chargées électriquement, est agencée pour charger les particules par voie triboélectrique.
13. Presse rotative selon l'une quelconque des revendications 9 à 12, dans laquelle l'alimentation (18) pour amener des particules chargées électriquement, comporte un châssis d'alimentation (17) réalisé de matériau électriquement isolant, disposé devant le poste de remplissage et agencé pour recevoir les particules de lubrifiant chargées avant leur attraction sur les poinçons (3, 5) et dans les matrices (2).
EP86309565A 1985-12-10 1986-12-09 Fabrication de comprimés Expired EP0225803B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB858530365A GB8530365D0 (en) 1985-12-10 1985-12-10 Manufacture of moulded products
GB8530365 1985-12-10

Publications (2)

Publication Number Publication Date
EP0225803A1 EP0225803A1 (fr) 1987-06-16
EP0225803B1 true EP0225803B1 (fr) 1990-10-24

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US (2) US4832880A (fr)
EP (1) EP0225803B1 (fr)
JP (1) JPS62187598A (fr)
CN (1) CN86108594A (fr)
DE (1) DE3675169D1 (fr)
ES (1) ES2019065B3 (fr)
GB (2) GB8530365D0 (fr)

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DE3675169D1 (de) 1990-11-29
EP0225803A1 (fr) 1987-06-16
GB8530365D0 (en) 1986-01-22
CN86108594A (zh) 1987-07-01
US5017122A (en) 1991-05-21
US4832880A (en) 1989-05-23
ES2019065B3 (es) 1991-06-01
JPS62187598A (ja) 1987-08-15
GB2183538A (en) 1987-06-10
GB8629359D0 (en) 1987-01-21
GB2183538B (en) 1989-10-25

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